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FDA Releases Definitive Statement on Fake Registration Certificates

On March 3, 2021, FDA issued a statement acknowledging that certain entities produce certificates of registration for medical device manufacturers and clarifying that the agency does not issue such certificates. The agency also announced that it sent letters to 25 entities demanding that they stop producing these false and misleading certificates because some device manufacturers and distributors are using them to claim that the devices they produce or sell are cleared, approved, or otherwise authorized by FDA. It is important to add that FDA likewise does not issue certificates of registration for facilities that manufacture or otherwise handle drugs, biologics, cosmetics, or food. Registration with FDA as a food, drug, biologic, or device establishment simply includes the company name in the agency's respective establishment database (registration as a cosmetic establishment is voluntary).

Although FDA’s announcement was precipitated by an increase in the deceptive use of fraudulent certificates during the pandemic to make it seem as though personal protective equipment or other medical devices were reviewed and authorized by FDA, the practice of creating such certificates has been going on for years. Our FDA practice has seen many situations in which unsuspecting importers looking to bring medical device products into the United States for distribution, or even business entities performing due diligence on potential investment or acquisition targets, forward these fraudulent registration certificates to us as proof that a medical device made by the foreign manufacturer is cleared or approved by FDA. These certificates are especially misleading when a company manufactures class I or unclassified devices (e.g., face masks for general use (product code QKR) or those authorized through the EUA process (product code QMF)) that do not require FDA clearance or approval prior to commercialization.

While the certificates typically include the business name of the manufacturer, descriptions of the devices produced by the manufacturer, as well as FDA's logo and a makeshift bald eagle and American flag logo, they merely state the date on which the manufacturer was registered with FDA and are signed by the consultant or other individual who completed the registration process for the manufacturer. Such certificates never bear the signature of an FDA official or employee.

In addition to the statement issued on March 3, FDA also created a webpage titled, Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?, with helpful clarifications on the terms “FDA Registered,” “FDA Certified,” and “FDA Registration Certificate” as well as resources for determining whether a medical device has been cleared or approved by the agency.

This announcement and the new webpage dedicated to clarifying the FDA registration certificate issue are significant steps towards educating the public and industry stakeholders of these fraudulent and misleading activities.

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Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.